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Drug Eluting Balloon in peripherAl inTErvention SFA (DEBATE SFA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01556542
First Posted: March 16, 2012
Last Update Posted: January 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato
  Purpose
The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.

Condition Intervention Phase
Peripheral Arterial Disease Device: paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation Device: nitinol stent implantation Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Drug Eluting Balloon in peripherAl inTErvention: the DEBATE SFA Study

Resource links provided by NLM:


Further study details as provided by Leonardo Bolognese, MD, Ospedale San Donato:

Primary Outcome Measures:
  • angiographic binary restenosis [ Time Frame: 12 months ]
    incidence of binary restenosis


Secondary Outcome Measures:
  • major amputation [ Time Frame: 24 months ]
    incidence of major amputation

  • target lesion revascularization [ Time Frame: 24 months ]
    incidence of target lesion revascularization

  • vessel reocclusion [ Time Frame: 24 months ]
    incidence of vessel reocclusion


Enrollment: 104
Study Start Date: November 2010
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard PTA
nitinol stent implantation
Device: nitinol stent implantation
nitinol stent implantation
Experimental: DEB
paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
Device: paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age>18 years
  • intermittent claudication(Fontane III or IV)
  • angiographic stenosis>50% or occlusion of superficial femoral-popliteal artery>40mm
  • at least one below-knee vessel to the ankle

Exclusion Criteria:

  • allergy to Paclitaxel
  • contraindication for combined antiplatelet treatment
  • life expectancy <1 year
  • hypersensitivity or contraindication to one of the study drugs
  • lack of consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556542


Locations
Italy
Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy, 52100
Sponsors and Collaborators
Leonardo Bolognese, MD
Investigators
Principal Investigator: Francesco Liistro, MD Cardiovascular Department, San Donato Hospital, Arezzo, Italy
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Leonardo Bolognese, MD, Director of Cardiovascular Department, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT01556542     History of Changes
Other Study ID Numbers: Arezzo004
First Submitted: March 13, 2012
First Posted: March 16, 2012
Last Update Posted: January 29, 2013
Last Verified: January 2013

Keywords provided by Leonardo Bolognese, MD, Ospedale San Donato:
peripheral arterial disease
drug-eluting balloon
restenosis

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action